NCT06058923

MIST Versus M-MIST for the Treatment of Intrabony Defects

Active, enrolled NA Last updated 23 January 2026

What this trial tests

NA trial testing M-MIST in Periodontitis in 50 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

10 August 2023

Primary endpoint
30 June 2026

10 July 2026

Quick facts

Lead sponsor	University of Campinas, Brazil
Phase	NA
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	50
Start date	10 August 2023
Primary completion	30 June 2026
Estimated completion	10 July 2026
Sites	1 location across Brazil

Drugs / interventions tested

• M-MIST
• MIST

Conditions studied

• Periodontitis — all drugs for Periodontitis →
• Intrabony Periodontal Defect — all drugs for Intrabony Periodontal Defect →
• Periodontitis, Chronic — all drugs for Periodontitis, Chronic →

Sponsor

University of Campinas, Brazil

Who can join

21 and older, any sex, with Periodontitis or Intrabony Periodontal Defect. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a 12-month longitudinal, double-blind, parallel-design randomized controlled clinical trial involving surgical therapeutic intervention (Phase 4). It will include 50 participants aged 21 diagnosed with periodontitis (Stage III/IV, Grade A or B), divided into a Test Group (n=25, Minimally invasive single-flap surgery) and a Control Group (n=25, Minimally invasive double-flap surgery). The objective of this randomized, double-blind clinical study is to compare clinical, radiographic, and patient-centered outcomes between minimally invasive single-flap and double-flap techniques in treating isolated infra-bony defects. Twenty-five patients will be treated using the single-flap approach, and 25 patients will receive the double-flap elevation technique. Clinical parameters (plaque and bleeding scores, probing depth, gingival recession, clinical attachment level, and papillary dimensions), digital measurements (changes in gingival margin and papillary volume), radiographic assessments, and patient-centered outcomes (VAS scale) will be evaluated immediately before surgery, at 6 and 12 months post-procedure, while early healing will be assessed after 1 and 2 weeks following the procedures. Mean values and standard deviations will be calculated for each variable, normal distribution will be tested using the Shapiro-Wilk test, and comparisons will be conducted using Student's t-test and one-way ANOVA. A significance level of 5% will be used for all analyses.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.